Systems and methods for parenterally procuring bodily-fluid samples with reduced contamination

ABSTRACT

The present invention is directed to the parenteral procurement of bodily-fluid samples. The present invention is also directed to systems and methods for parenterally procuring bodily-fluid samples with reduced contamination from dermally-residing microbes. In some embodiments, a bodily-fluid withdrawing system is used to withdraw bodily fluid from a patient for incubation in culture media in one or more sample vessels. Prior to withdrawing bodily fluid into the one or more sample vessels for incubation, an initial volume of withdrawn bodily fluid is placed in one or more pre-sample reservoirs and is not used for the incubation in culture media.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 60/870,599, filed Dec. 18, 2006, the entire contents of which isincorporated herein by reference.

TECHNICAL FIELD

The present invention is directed to the parenteral procurement ofbodily-fluid samples. The present invention is also directed to systemsand methods for parenterally procuring bodily-fluid samples with reducedcontamination from dermally-residing microbes.

BACKGROUND

Health care professionals routinely perform various types of microbialtests on patients using parenterally-obtained patient bodily fluids.Contamination of parenterally-obtained bodily fluids by microbes mayresult in spurious microbial test results. Spurious microbial testresults may be a concern when attempting to diagnose or treat asuspected illness or condition. False positive results from microbialtests can cause a patient to be unnecessarily subjected to one or moreanti-microbial therapies, such as anti-bacterial or anti-fungaltherapies, which may cause anguish and inconvenience to the patient, aswell as produce an unnecessary burden and expense to the health caresystem.

BRIEF DESCRIPTION OF THE DRAWINGS

Non-limiting and non-exhaustive embodiments of the present invention aredescribed with reference to the following drawings. In the drawings,like reference numerals refer to like parts throughout the variousfigures unless otherwise specified.

For a better understanding of the present invention, reference will bemade to the following Detailed Description, which is to be read inassociation with the accompanying drawings, wherein:

FIG. 1 is a schematic view of one embodiment of a sample-procurementsystem, according to the invention;

FIG. 2 is a schematic cross-sectional view of one embodiment of a firstneedle of a sample-procurement system inserted into a patient vein;according to the invention;

FIG. 3A is a schematic view of one embodiment of a bodily-fluidwithdrawing device draining blood from a patient vein into a pre-samplereservoir, according to the invention;

FIG. 3B is a schematic view of one embodiment of a bodily-fluidwithdrawing device draining blood from a patient vein into a samplevessel, according to the invention;

FIG. 4A is a schematic view of another embodiment of asample-procurement system with multiple sample vessels being used todrain blood from a patient to a pre-sample reservoir, according to theinvention;

FIG. 4B is a schematic view of the embodiment of the sample-procurementsystem shown in FIG. 4A being used to drain blood from a patient to apre-sample reservoir with a splash guard positioned over the secondneedle, according to the invention;

FIG. 5 is a schematic view of another embodiment of a sample-procurementsystem with a diversion mechanism in a bodily-fluid withdrawing device,according to the invention;

FIG. 6A is a schematic close-up view of one embodiment of a diversionmechanism that includes a switchable valve in a first position,according to the invention;

FIG. 6B is a schematic close-up view of the diversion mechanism shown inFIG. 6A in a second position, according to the invention;

FIG. 7A is a schematic close-up view of a second embodiment of adiversion mechanism that includes two flow-control blocks in a firstposition, according to the invention;

FIG. 7B is a schematic close-up view of the diversion mechanism shown inFIG. 7A in a second position, according to the invention;

FIG. 8 illustrates a flow diagram showing one embodiment of exemplarysteps used for procuring samples, according to the invention;

FIG. 9 illustrates a flow diagram showing a second embodiment ofexemplary steps used for procuring samples, according to the invention.

DETAILED DESCRIPTION

The present invention is directed to the parenteral procurement ofbodily-fluid samples. The present invention is also directed to systemsand methods for parenterally procuring bodily-fluid samples with reducedcontamination from dermally-residing microbes. In some embodiments, abodily-fluid withdrawing system is used to withdraw bodily fluid from apatient for incubation in culture media in one or more sample vessels.Prior to withdrawing bodily fluid into the one or more sample vesselsfor incubation, an initial volume of withdrawn bodily fluid is placed inone or more pre-sample reservoirs and is not used for the incubation inculture media.

Health care professionals routinely procure parenterally-obtainedbodily-fluid samples (“samples”) from patients. Patient samples mayinclude many different types of bodily fluids. For example, patientsamples may include blood, cerebrospinal fluid, urine, bile, lymph,saliva, synovial fluid, serous fluid, pleural fluid, amniotic fluid, andthe like. Patient samples are sometimes tested for the presence of oneor more potentially undesirable microbes, such as bacteria, fungi, orCandida. Microbial testing may include incubating patient samples in oneor more sterile vessels containing culture media that is conducive tomicrobial growth. Generally, when microbes tested for are present in thepatient sample, the microbes flourish over time in the culture medium.After a pre-determined amount of time, the culture medium can be testedfor the presence of the microbes. The presence of microbes in theculture medium suggests the presence of the same microbes in the patientsample which, in turn, suggests the presence of the same microbes in thebodily-fluid of the patient from which the sample was obtained.Accordingly, when microbes are determined to be present in the culturemedium, the patient may be prescribed one or more antibiotics or othertreatments specifically designed to remove the undesired microbes fromthe patient.

Patient samples can sometimes become contaminated during procurement.Contamination of a patient sample may result in a spurious microbialtest result which, in turn, may cause the patient to unnecessarilyundergo one or more microbial-removal treatments. One way in whichcontamination of a patient sample may occur is by the transfer ofdermally-residing microbes dislodged during needle insertion into apatient and subsequently transferred to a culture medium with thepatient sample. The dermally-residing microbes may be dislodged eitherdirectly or via dislodged tissue fragments. The transferred microbes maythrive in the culture medium and eventually yield a positive microbialtest result, thereby falsely indicating the presence of microbes invivo.

FIG. 1 is a schematic view of one embodiment of a sample-procurementsystem 100. The sample-procurement system 100 includes a bodily-fluidwithdrawing device 102, one or more pre-sample reservoirs 104, and oneor more culture-medium-containing sample vessels 106 (“sample vessels”).In FIG. 1 (and in subsequent Figures), a single pre-sample reservoir 104is shown and represents either one pre-sample reservoir 104 or aplurality of pre-sample reservoirs 104. Likewise, FIG. 1 (and subsequentFigures) shows a single sample vessel 106 that represents either onesample vessel 106 or a plurality of sample vessels 106.

The bodily-fluid withdrawing device 102 includes a first sterile needle108 (“first needle”) and a second sterile needle 110 (“second needle”)coupled to the first needle 108. The first needle 108 includes a distalend 112, a proximal end 114, and a lumen (see FIG. 2) extending from thedistal end 112 to the proximal end 114. The distal end 112 is configuredand arranged for puncturing through multiple layers of patient skin andthe proximal end 114 is configured and arranged for attachment withsterile, lumen-containing devices. The lumen (see FIG. 2) is configuredand arranged for passing bodily-fluids from the distal end 112 of thefirst needle 108 to the proximal end 114.

The second needle 110 includes a distal end 116 configured and arrangedfor puncturing septa disposed over pre-sample reservoirs 104 and samplevessels 106, a proximal end 118 configured and arranged for attachmentwith other sterile, lumen-containing devices, and a lumen (not shown)extending from the distal end 116 to the proximal end 118. The firstneedle 108 and the second needle 110 can be manufactured using anyrigid, sterilizable, biocompatible material suitable for penetrating theskin of a patient, septa 122 disposed over pre-sample reservoir 104, orsepta 128 disposed over sample vessels 106. Exemplary materials mayinclude stainless steel, and the like. In at least some embodiments, thefirst needle 108 and the second needle 110 are selected from theVacutainer™ blood collection set, manufactured by Becton Dickinson.

In at least some embodiments, the proximal end 114 of the first needle108 couples directly to the proximal end 118 of the second needle 110.In other embodiments, the proximal end 114 of the first needle 108couples, via one or more sterile, intermediary, lumen-containingdevices, to the proximal end 118 of the second needle 110. In FIG. 1, aflexible sterile tubing 120 is shown coupling the proximal end 114 ofthe first needle 108 to the proximal end 118 of the second needle 110.The sterile tubing 120 can be manufactured using any flexible,sterilizable, biocompatible material suitable for containing bodilyfluids. Exemplary materials may include plastic, silicone rubber, andthe like.

Each of the one or more pre-sample reservoirs 104 is sterile andincludes a septum 122 covering a mouth 124 of each of the pre-samplereservoirs 104. Each septum 122 seals the mouth 124 and maintains aninternal vacuum inside the pre-sample reservoir 104. In at least someembodiments, the septum 122 is held in place by a crimp ring 126.Likewise, each of the one or more sample vessels 106 is sterile andincludes an internal vacuum maintained by a septum 128 covering a mouth130 of each of the one or more sample vessels 106. In at least someembodiments, the septum 128 is held in place by a crimp ring 132. Theone or more pre-sample reservoirs 104 and the one or more sample vessels106 can be manufactured using any sterilizable, biocompatible materialsuitable for containing bodily fluids and culture media, or any othertesting additives. Exemplary materials may include glass, plastic, andthe like. In at least one embodiment, the first needle 108, the secondneedle 110, the sterile tubing 120, the one or more pre-samplereservoirs 104, and one or more sample vessels 106 are all disposable.

Each of the one or more sample vessels 106 contains a culture medium 134for growing selected microbes. A culture medium may contain differentamounts of different components, depending on the type of microbes beingdetected. A culture medium may include, for example, a nutrient brothwith a carbon source, a nitrogen source, salts, water, and an amino acidsource. Additionally, sample vessels undergoing microbial testing may beincubated at a specific temperature to further facilitate growth of atested microbe.

Examples of the sample-procurement system are shown in FIGS. 1-7, andalso discussed in reference to FIGS. 1-7, in terms of procuring bloodsamples from a patient vein. Procuring blood from a patient vein ismeant to serve as one of many possible types of bodily fluidsparenterally withdrawn from one of many possible body locations. FIG. 2is a schematic cross-sectional view of the first needle 108 insertedinto a lumen of a vein 202 of a patient. The distal end 112 of the firstneedle 108 is shown extending through multiple layers of skin 204 and alayer of subcutaneous fat 206. The first needle 108 includes a lumen 208extending along the length of the first needle 108. When the distal end112 of the first needle 108 is inserted into a fluid-containing portionof a body, such as the lumen of the vein 202, fluid within thefluid-containing portion of the body may be withdrawn from thefluid-containing portion of the body by passing the fluid through thelumen 208 of the first needle 108.

In at least some embodiments, prior to penetration with the first needle108 patient skin is cleansed with one or more disinfectants to reducethe number of microbes on an outer surface of the patient skin. Forexample, patient skin can be cleansed with a gauze pad soaked with adisinfectant. Many different types of disinfectants may be used tocleanse patient skin. In one embodiment, patient skin is cleansed with adisinfectant that includes a 70% isopropyl alcohol solution, with 2%Chlorhexidine Gluconate, manufactured by MediFlex, Inc.

Once the first needle 108 is inserted into a desired fluid-containingbody location, the second needle 110 is inserted into the pre-samplereservoir 104 and blood is withdrawn into the one or more pre-samplereservoirs 104. FIG. 3A is a schematic view of one embodiment of thebodily-fluid withdrawing device 102 being used to procure blood from thevein 202 of a patient and depositing the blood in the one or morepre-sample reservoirs 104. In FIG. 3A, the first needle 108 is shownextending through a patient limb 302 and into the vein 202. The secondneedle 110 is in fluid communication with the first needle 108, eitherdirectly, or via one or more intermediary lumen-containing devices, suchas the sterile tubing 120. The second needle 112 is inserted through theseptum 122 and into the one or more pre-sample reservoirs 104, whichcontains an internal vacuum. In at least some embodiments, the insertionof the second needle 110 into the vacuum-sealed pre-sample reservoir 106creates a difference in pressure between the lumen of the first needle108 and the lumen of the second needle 110. The pressure change causesthe blood from the vein 202 to be transferred into the pre-samplereservoir 104 until the pressures equalize. Once the pressures equalizebetween the lumen of the first needle 108 and the lumen of the secondneedle 110, the blood tends to stop flowing from the vein 202 to thepre-sample reservoir 104. When the blood stops flowing into thepre-sample reservoir 104, the second needle can be removed and insertedinto another pre-sample reservoir or a sample reservoir.

Accordingly, the initial portion of blood withdrawn from the patient isdrawn into the pre-sample reservoir 104 and is not used for culturedmicrobial testing. In a preferred embodiment, the amount of bloodwithdrawn into the pre-sample reservoir 104 is at least equal to thecombined volumes of the lumen of the first needle 108, the lumen of thesecond needle 110, and the lumens of any intermediary lumen-containingdevices, such as the sterile tubing 120. Dermally-residing microbeswhich may have been dislodged into the lumen of the first needle 108during the insertion of the first needle 108 into the vein 202 may bewashed into the pre-sample reservoir 104, thereby reducing the microbialcontamination in the blood that is subsequently used as one or moresamples for cultured microbial tests.

The amount of blood transferred to the pre-sample reservoir 104 may beregulated by the size of the pre-sample reservoir 104. For example, arelatively large pre-sample reservoir may need to draw more blood toequalize pressure than a relatively small pre-sample reservoir. In atleast some embodiments, the one or more pre-sample reservoirs 104 areconfigured and arranged to hold approximately 1 ml to 5 ml. Thepre-sample reservoirs 104 may also include one or more additives. Forexample, in at least some embodiments, the pre-sample reservoirs 104 areBD Vacutainers™ with buffered citrate, manufactured by Becton Dickenson.

In at least some embodiments, blood collected in one or more pre-samplereservoirs is discarded. In other embodiments, blood collected in one ormore pre-sample reservoirs is used for conducting one or morenon-culture tests, such as one or more biochemical tests, blood counts,immunodiagnostic tests, cancer-cell detection tests, and the like. In atleast some embodiments, one or more pre-sample reservoirs may alsoinclude culture media for facilitating growth of one or more types ofmicrobes.

Once blood has been deposited in one or more pre-sample reservoirs, thesecond needle 112 may be inserted into a sample vessel. FIG. 3B is aschematic view of one embodiment of the bodily-fluid withdrawing device102 being used to procure blood from the vein 202 of a patient anddepositing the blood in the sample vessel 106. In at least someembodiments, the one or more sample vessels 106 are each vacuum-sealed.In a manner similar to the one or more pre-sample reservoirs 104, theinsertion of the second needle 110 into the vacuum-sealed sample vessel106 tends to cause blood from the vein 202 to be transferred into thesample vessel 106 until the pressures equalize.

In at least some embodiments, the amount of blood collected isdetermined based on the size of the sample vessel or the amount of bloodneeded to grow the microbes, if present, in the culture medium. In atleast some embodiments, the one or more sample vessels 106 areconfigured and arranged to receive approximately 2 ml to 10 ml of bodilyfluids in a sterile solid or liquid culture medium. In at least someembodiments, the one or more sample vessels 106 include the BacT/ALERT®SN and BacT/ALERT® FA, manufactured by BIOMERIEUX, INC.

As discussed above, in at least some embodiments a sample-procurementsystem includes one or more pre-sample reservoirs and one or more samplevessels. FIG. 4A illustrates one embodiment of a sample-procurementsystem 400 having a single pre-sample reservoir 402 and a plurality ofsample vessels 404. The culture medium contained in each of theplurality of sample vessels 402 can be the same or can be different. Forexample, in FIG. 4A a first sample vessel 406 includes a sterile fluidculture broth 408 for facilitating the growth of aerobic microbes, asecond sample vessel 410 includes a sterile fluid culture broth 412 forfacilitating the growth of anaerobic microbes, and a third sample vessel414 includes a sterile slant culture 416 for facilitating the growth offungi, or other microbes.

In at least some embodiments, a sample-procurement system can includeone or more accessory devices. FIG. 4B illustrates thesample-procurement system 400 having a splash guard 418 positioned overthe second needle 104. The splash guard 418 can be used to reduce therisk of undesirable blood splatter when the second needle 104 istransferred between the pre-sample reservoir 402 and each of the samplevessels 404.

In at least some embodiments, a sample-procurement system includes abodily-fluid withdrawing device with one or more intermediarylumen-containing devices, such as a diversion mechanism for divertingbodily fluid from the first needle to either one or more pre-samplereservoirs or to the second needle. FIG. 5 illustrates an alternateembodiment of a sample-procurement system 500. The sample-procurementsystem 500 includes a bodily-fluid withdrawing device 502, one or morepre-sample reservoirs 504, and one or more sample vessels 506. Thebodily-fluid withdrawing device 502 includes a first needle 508, asecond needle 510, a diversion mechanism 512, a flexible, sterile inputtubing 514, one or more first sterile output tubing 516, and a secondsterile output tubing 518.

In FIG. 5, the diversion mechanism 512 is shown as a dashed rectangle.The diversion mechanism 512 is discussed below in more detail, withreference to FIGS. 6A-7B. In at least some embodiments, the first needle508 is coupled to the diversion mechanism 512 via the flexible, sterileinput tubing 514. In at least some embodiments, the one or morepre-sample reservoirs 504 are coupled to the diversion mechanism 512 viathe one or more first sterile output tubing 516. In at least someembodiments, the second needle 510 is coupled to the diversion mechanism512 via the second sterile output tubing 518. In at least someembodiments, at least one pre-sample reservoir 504 is permanentlyattached to the bodily-fluid withdrawing device 502. In at least someembodiments, at least one pre-sample reservoir 504 is removably attachedto the bodily-fluid withdrawing device 502. In at least someembodiments, one or more of the tubing 514, 516, and 518 are omitted andone or more of the first needle 508, the pre-sample reservoir 504, andthe second needle 510, respectively, couple directly to the diversionmechanism 512.

The first needle 508 can be inserted into a patient to procure a bloodsample. In FIG. 5, the first needle 508 is shown inserted into a vein520. The second needle 510 is shown inserted into the one or more samplevessels 506 that have been vacuum-sealed. The vacuum in each of the oneor more sample vessels 506 causes blood to pass from the vein 520 to thediversion mechanism 512. The diversion mechanism 512 can be adjusted todivert the flow of blood to either the one or more pre-sample reservoirs504 or to the second needle 510 inserted into one of the one or moresample vessels 506. For example, in at least some embodiments, thediversion mechanism 512 can be initially adjusted to divert blood to theone or more pre-sample reservoirs 504 until the one or more pre-samplereservoirs 504 are filled, or a desired amount of blood has beenwithdrawn, at which point the diversion mechanism 512 can be adjusted todivert the flow of blood to the one or more sample vessels 506. In atleast some embodiments, the volume of blood withdrawn into the one ormore pre-sample reservoirs 504 is at least equal to the collectivevolumes of the first needle 508, the flexible, sterile input tubing 516,the diversion mechanism 512, and the first sterile output tubing 516.

Many different types of diversion mechanisms can be used to divert theflow of bodily fluids from a patient. FIG. 6A illustrates one embodimentof the diversion mechanism 512 that includes a switchable valve 602 thatpivots about a pivot point 604 positioned at the junction of the firststerile output tubing 516 and the second sterile output tubing 518. Theswitchable valve 602 can be placed in at least two positions: a firstposition (see FIG. 6A) and a second position (see FIG. 6B). When theswitchable valve 602 is in a first position, as shown in FIG. 6A, theswitchable valve 602 is positioned on the pivot point 604 so that theswitchable valve 602 creates a seal disallowing the flow of blood inputfrom the flexible, sterile input tubing 514 into the second sterileoutput tubing 518. Consequently, the blood flows into the pre-samplereservoir (not shown) via the first sterile output tubing 516.

FIG. 6B illustrates one embodiment of the switchable valve 602 in asecond position. When the switchable valve 602 is in a second position,the switchable valve 602 is positioned on the pivot point 604 so thatthe switchable valve 602 creates a seal disallowing the flow of bloodinput from the flexible, sterile input tubing 514 into the pre-samplereservoir (not shown) via the first sterile output tubing 516.Consequently, the blood flows into the one or more sample vessels (notshown) via the second sterile output tubing 518. In at least someembodiments, the diversion mechanism 512 includes more than twopositions. In which case, each position may correspond to blood-flowdiversion to a unique output tubing. In some embodiments, a plurality ofpre-sample reservoirs may be used. In which case, each pre-samplereservoir may correspond to a unique diversion-mechanism position. Thus,in at least some embodiments, one position corresponds to divertingblood flow to the second needle and the other positions each correspondto a unique pre-sample reservoir.

In at least some embodiments, the switchable valve can be manuallyswitched between two or more positions by coupling an external switch tothe switchable valve that can be operated either manually orelectronically. In at least some embodiments, the external switch isexternal to each of the lumens of the bodily-fluid withdrawing device.In at least some embodiments, the switchable valve can be eithermanually or automatically switched between two or more of the positionsby using sensors to sense when to switch a switchable valve, or timersto time when to switch a switchable valve.

FIG. 7A illustrates another embodiment of the diversion mechanism 512that includes an input flow-control block 702 and a slidably-mountedoutput flow-control block 704 that slides along a shared edge with theinput flow-control block 702. The input flow-control block 702 and theoutput flow-control block 704 can be slid back and forth between a firstposition (see FIG. 7A) and a second position (see FIG. 7B). The inputflow-control block 702 is configured and arranged to couple with theflexible, sterile input tubing 514. The input flow-control block 702includes a lumen 706 extending through the input flow-control block 702from the flexible, sterile input tubing 514 to the shared edge with theoutput flow-control block 704.

The output flow-control block 704 is configured and arranged to couplewith the first sterile output tubing 516 and the second sterile outputtubing 518. The output flow-control block 704 includes a first lumen 708extending through the output flow-control block 704 from the shared edgewith the input flow-control block 702 to the first sterile output tubing516, and a second lumen 710 also extending through the outputflow-control block 704 from the shared edge with the input flow-controlblock 702 to the second sterile output tubing 518. When the inputflow-control block 702 and the output flow-control block 704 are in afirst position relative to one another, the lumen 706 on the inputflow-control block 702 aligns with the first lumen 708 on the outputflow-control block 704. Accordingly, the flow of blood input from theflexible, sterile input tubing 514 passes through the lumen 706 of theinput flow-control block 702 and through the first lumen 708 of theoutput flow-control block 704 and into the pre-sample reservoir (notshown) via the first sterile output tubing 516.

In at least some embodiments, once a desired amount of blood is divertedto the one or more pre-sample reservoirs, the flow-control blocks can beslid to a second position to divert blood flow to the second needle,which may be inserted into one of the one or more sample vessels. FIG.7B illustrates one embodiment of the input flow-control block 702 andthe output flow-control block 704 in a second position. When the inputflow-control block 702 and the output flow-control block 704 are in asecond position relative to one another, the lumen 706 on the inputflow-control block 702 aligns with the second lumen 710 on the outputflow-control block 704. Accordingly, the flow of blood input from theflexible, sterile input tubing 514 passes through the lumen 706 of theinput flow-control block 702 and through the second lumen 710 of theoutput flow-control block 704 and into the one or more sample vessels(not shown) via the second sterile output tubing 518. In at least someembodiments, the output flow-control block 704 includes additionallumens that correspond to different positions which, in turn, maycorrespond to blood diversion to other pre-sample reservoirs, eitherdirectly, or via one or more intermediary output tubing.

FIG. 8 illustrates a flow diagram showing one embodiment of exemplarysteps used for procuring samples. In step 802, a first needle isinserted into a desired bodily-fluid-containing portion of a patient. Instep 804, a second needle is inserted into a pre-sample reservoir. Instep 806, a predetermined amount of bodily fluid is drained from thepatient into the pre-sample reservoir. In step 808, the second needle isremoved from the pre-sample reservoir. When, in step 810, there isanother pre-sample reservoir to drain bodily fluid into, control ispassed back up to step 804. Otherwise, control passes to step 812, wherethe second needle is inserted into a sample vessel. In step 814, apredetermined amount of bodily fluid is drained from the patient intothe sample vessel. In step 816, the second needle is removed from thesample vessel. When, in step 818, there is another sample vessel todrain bodily fluid into, control is passed back up to step 812.Otherwise, in step 820 the first needle is removed from the patient andthe flow ends.

FIG. 9 illustrates a flow diagram showing a second embodiment ofexemplary steps used for procuring samples. In step 902, a first needleis inserted into a desired bodily-fluid containing portion of a patient.In step 904, a second needle is inserted into a pre-sample reservoir. Instep 906, a diversion mechanism is adjusted to direct the flow of bodilyfluids to a desired pre-sample reservoir. In step 908, a predeterminedamount of bodily fluid is drained from the patient into the pre-samplereservoir. When, in step 910, there is another pre-sample reservoir todrain bodily fluid into, control is passed back up to step 906.Otherwise, control passes to step 912, where the diversion mechanism isadjusted to divert bodily fluids to a sample vessel. In step 914, apredetermined amount of bodily fluid is drained from the patient intothe sample vessel. In step 916, the second needle is removed from thesample vessel. When, in step 918, there is another sample vessel todrain bodily fluid into, control is passed to step 920, where the secondneedle is inserted into another sample vessel, and then control ispassed back to step 914. Otherwise, in step 922 the first needle isremoved from the patient and the flow ends.

Other alternate embodiments of the methods and systems described aboveinclude using a sterile syringe with at least two reservoirs. Forexample, in at least some embodiments, a sterile syringe with alumen-containing needle and a removable first reservoir can be used fordrawing and collecting pre-sample bodily-fluids from a patient. In atleast some embodiments, the volume of collected pre-sample bodily-fluidsis equal to, or greater than, the volume of the lumen of the needle.Once the desired amount of pre-sample bodily-fluids are collected, thefirst reservoir can be removed and a second reservoir can then beattached to the needle, already in place in the vein. In at least someembodiments, sample bodily-fluids can be drawn and collected in thesecond reservoir and subsequently be transferred to one or more samplevessels to undergo microbial testing.

A study has been performed in which blood was drawn from patients eitherwith or without separating initially-drawn blood into one or morepre-sample reservoirs. The data from the study has been provided belowin Table 1.

TABLE 1 No. of false No. of correct positives negatives Using pre-sample77 1911 1988 reservoir Without using pre- 48 580 628 sample reservoir125 2491 2616

In the data shown in Table 1, blood was drawn for microbial testing frompatients at a single hospital by a group of licensed phlebotomists. Ofthe patients from which blood was drawn, 125 patients tested positivefor the presence of dermal contaminating microbes (false positives). Ofthe 2616 patients tested for the presence of microbes, 1988 had aninitial volume of drawn blood sequestered into a pre-sample reservoirthat was not used for the microbial testing, while 628 patients did not.Of the patients from which a pre-sample reservoir was used, 77 of the1988 test results were later determined to be false positive results,while 48 of the 628 test results from the patients for which initialblood volumes were used for microbial testing were later determined tobe false positive results. The data suggests that fewer false positivetest results occur when initial volumes of drawn blood are not used formicrobial testing.

A Pearson's Chi-Square Test was performed on the data from Table 1 andis provided below as Formula (1)

$\begin{matrix}{\frac{\begin{matrix}{\left\lbrack {\left( {77 \times 580} \right) - \left( {48 \times 1911} \right)} \right\rbrack 2 \times} \\\left( {77 + 48 + 1911 + 580} \right)\end{matrix}}{\begin{matrix}{\left( {77 + 1911} \right) \times \left( {48 + 580} \right) \times} \\{\left( {1911 + 580} \right) \times \left( {77 + 48} \right)}\end{matrix}} = 14.91} & {{Formula}\mspace{14mu} (1)}\end{matrix}$

For the data shown in Table 1, there are two possible results: a correct(true) negative, and a false positive. The number of degrees of freedomis equal to the number of possible results minus one. A listing ofvarious Chi-square probability values for 1 degree of freedom areprovided in Table 2

TABLE 2 Probability 0.50 0.20 0.15 0.10 0.05 0.02 0.01 0.001 1 degree of0.46 1.64 2.07 2.71 3.84 5.41 6.63 10.83 freedom

As shown in Formula 1, the Chi-square value of the data shown in Table 1is 14.91, which is higher than the probability of the result occurringby chance alone is less than one time out of a thousand. Thus, the datasuggests that fewer false positive test results for the presence ofmicrobes in blood are obtained over conventional methods wheninitially-drawn volumes of blood are not used in microbial testing.

The above specification, examples and data provide a description of themanufacture and use of the composition of the invention. Since manyembodiments of the invention can be made without departing from thespirit and scope of the invention, the invention also resides in theclaims hereinafter appended.

1.-20. (canceled)
 21. An apparatus for obtaining a bodily fluid samplefrom a patient comprising: a lumen-containing device configured to befluidically coupled to a patient; a reservoir configured to befluidically coupled to the lumen-containing device and to receive andsequester an initial volume of bodily fluid withdrawn from the patient;and a diverter fluidically coupled to the lumen-containing device andoperable to control fluid flow between the lumen-containing device andat least one of the reservoir and a sample reservoir, the diverterhaving a first state such that fluid communication is establishedbetween the lumen-containing device and the reservoir, and a secondstate such that fluid communication is established between thelumen-containing device and the sample reservoir.
 22. The apparatus ofclaim 21, further comprising: a needle having a lumen fluidicallycoupled to the lumen-containing device.
 23. The apparatus of claim 22,wherein the initial volume of bodily fluid is greater than the lumen ofthe needle.
 24. The apparatus of claim 22, wherein the initial volume ofbodily fluid is greater than the lumen of the needle and less than 5 ml.25. The apparatus of claim 21, wherein the initial volume of bodilyfluid is approximately 0.5 ml to 3 ml.
 26. The apparatus of claim 21,wherein the diverter defines a first fluid flow path that allows theinitial volume of bodily fluid to flow from the lumen-containing deviceto the reservoir in the first state, and a second fluid flow path thatallows a subsequent volume of bodily fluid to flow from thelumen-containing device to the sample reservoir in the second state. 27.The apparatus of claim 26, wherein the diverter sequesters the initialvolume of bodily fluid in the reservoir in the second state.
 28. Theapparatus of claim 21, wherein the diverter is configured to be manuallytransitioned from the first state to the second state.
 29. The apparatusof claim 21, wherein the diverter is configured to be electronicallytransitioned from the first state to the second state.
 30. The apparatusof claim 21, wherein the diverter is configured to be automaticallytransitioned from the first state to the second state.
 31. An apparatusfor obtaining a bodily fluid sample from a patient comprising: a needlehaving a lumen configured for insertion into the patient; an input tubefluidically coupled to the needle; a diverter fluidically coupled to theinput tube; a reservoir configured to receive and sequester an initialvolume of bodily fluid withdrawn from the patient; and an output tubefluidically coupled to the diverter, the diverter operable in a firststate such that fluid communication is established between the inputtube and the reservoir, and in a second state such that fluidcommunication is established between the input tube and the output tube.32. The apparatus of claim 31, wherein the needle is a first needle, theapparatus further comprising a second needle fluidically coupleable tothe output tube.
 33. The apparatus of claim 31, wherein the initialvolume of bodily fluid is greater than the lumen of the needle and lessthan 5 ml.
 34. The apparatus of claim 31, wherein the diverter defines afirst fluid flow path that allows the initial volume of bodily fluid toflow from the input tube to the reservoir in the first state, and asecond fluid flow path that allows a subsequent volume of bodily fluidto flow from the input tube to the output tube in the second state. 35.The apparatus of claim 34, wherein the diverter sequesters the initialvolume of bodily fluid in the reservoir in the second state.
 36. Theapparatus of claim 35, whereby sequestering the initial volume of bodilyfluid in the reservoir sequesters contaminants present in the initialvolume of bodily fluid thereby reducing contamination of the subsequentvolume of bodily fluid withdrawn from the patient.
 37. An apparatus forobtaining a bodily fluid sample from a patient comprising: a firstneedle having a lumen configured for insertion into the patient; anoutput tube configured to be fluidically coupled to the first needle;and an intermediary lumen-containing device configured to establishfluid communication between the first needle and the output tube, theintermediary lumen-containing device configured to transfer an initialvolume of bodily fluid from the first needle to a pre-sample reservoirwhen in a first state, the initial volume of bodily fluid being (a)greater than the volume of the lumen of the first needle, and (b) lessthan 5 ml, the intermediary lumen-containing device configured totransfer a subsequent volume of bodily fluid to a sample reservoir viathe output tube when in a second state, whereby transferring the initialvolume of bodily fluid to the pre-sample reservoir sequesterscontaminants present in the initial volume of bodily fluid therebyreducing contamination of the subsequent volume of bodily fluidwithdrawn from the patient.
 38. The apparatus of claim 37, wherein theintermediary lumen-containing device defines a first fluid flow paththat allows the initial volume of bodily fluid to flow from the firstneedle to the pre-sample reservoir in a first state, and a second fluidflow path that allows the subsequent volume of bodily fluid to flow fromthe first needle tube to the output tube in a second state.
 39. Theapparatus of claim 37, wherein the pre-sample reservoir is integratedinto the intermediary lumen-containing device.
 40. The apparatus ofclaim 37, wherein the intermediary lumen-containing device includes anoutlet and the output tube is fluidically coupled to the outlet.
 41. Theapparatus of claim 37, wherein the intermediary lumen-containing deviceincludes a diverter configured to be automatically transitioned from thefirst state to the second state.
 42. An apparatus for obtaining a bodilyfluid sample from a patient comprising: a first lumen-containing deviceconfigured to be fluidically coupled to a patient; an outputlumen-containing device configured to be fluidically coupled to thefirst lumen-containing device; and an intermediary lumen-containingdevice configured to establish fluid communication between the firstlumen-containing device and the output lumen-containing device, theintermediary lumen-containing device including a reservoir configured toreceive and sequester an initial volume of bodily fluid withdrawn fromthe patient, the intermediary lumen-containing device configured totransfer the initial volume of bodily fluid from the firstlumen-containing device to the reservoir when in a first state, theintermediary lumen-containing device configured to transfer a subsequentvolume of bodily fluid to the output lumen-containing device when in asecond state, whereby transferring the initial volume of bodily fluid tothe reservoir sequesters contaminants present in the initial volume ofbodily fluid thereby reducing contamination of the subsequent volume ofbodily fluid withdrawn from the patient.
 43. The apparatus of claim 42,wherein the first lumen-containing device is a needle having a lumenconfigured for insertion into the patient.
 44. The apparatus of claim43, wherein the initial volume of bodily fluid is greater than the lumenof the needle.
 45. The apparatus of claim 43, wherein the initial volumeof bodily fluid is greater than the lumen of the needle and less than 5ml.
 46. The apparatus of claim 42, wherein the intermediarylumen-containing device defines a first fluid flow path that allows theinitial volume of bodily fluid to flow from the first lumen-containingdevice to the reservoir in the first state, and a second fluid flow paththat allows the subsequent volume of bodily fluid to flow from the firstlumen-containing device to the output lumen-containing device in thesecond state.
 47. The apparatus of claim 46, wherein the intermediarylumen-containing device sequesters the initial volume of bodily fluid inthe reservoir in the second state.
 48. The apparatus of claim 42,wherein the intermediary lumen-containing device includes a diverterconfigured to be manually transitioned from the first state to thesecond state.
 49. The apparatus of claim 42, wherein the intermediarylumen-containing device includes a diverter configured to beelectronically transitioned from the first state to the second state.50. The apparatus of claim 42, wherein the intermediary lumen-containingdevice includes a diverter configured to be automatically transitionedfrom the first state to the second state.